(173 days)
The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only. The GDS® GlucoSite® Test Card is ultagi looks are quantitative determination of glucose in whole blood. It is intended for use with the Stat-Site® Meter.
This whole blood glucose test system consists of a GlucoSite® Test Card, test card specific Test Module, and a portable, hand held Stat-Site® electronic reflectance photometer (Meter). The test method employs a dry reagent technology based on the glucose oxidase method and is specific for D-Glucose. When a drop of whole blood is applied to the top opening on the test card, the red blood cells are separated allowing only the plasma to pass through. Glucose oxidase catalyzes the oxidation of the glucose in the plasma to produce gluconic acid and hydrogen peroxide in the presence of atmospheric oxygen. The second enzyme peroxidase then catalyzes the reduction of hydrogen peroxide in presence of 4-amino-antipyrine with concomitant oxidation of the chromogen TOOS [N-ethyl-N-(2-hydroxy-3sulfopropyl)-m-toluidine] to produce a purple color that is measured at 660 nm. The intensity of color developed is correlated with the glucose concentration in the whole blood sample. The Stat-Site® Meter measures the reflectance of the color produced at 660 nm and converts the reflectance reading to corresponding plasma glucose values.
Here's a breakdown of the acceptance criteria and the study details for the GlucoSite® Test System:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Correlation with YSI 2300 STAT PLUS Analyzer (Predicate Method): | Slope: 1.008 | |
| Intercept: -2.996 | ||
| Correlation Coefficient (r): 0.99 | These values indicate a strong linear relationship and close agreement with the predicate device. An 'r' value of 0.99 signifies excellent correlation. | |
| Correlation with Hexokinase Method (Reference Method): | Slope: 1.000 | |
| Intercept: -11.425 | ||
| Correlation Coefficient (r): 0.99 | Another strong linear relationship and excellent agreement with the Hexokinase reference method, providing further validation of accuracy. | |
| Correlation of Finger Stick Blood (GlucoSite) with Venous Plasma (YSI): | Slope: 0.999 | |
| Intercept: 5.473 | ||
| Correlation Coefficient (r): 0.965 | This demonstrates a good correlation between the device's finger stick results and established plasma glucose values, indicating clinical utility for the intended sample type. | |
| Total Coefficient of Variation (T-CV) for Precision: | Below 5% for glucose concentrations of 50, 80, 150, and 350 mg/dL | This demonstrates good precision across the measurable range, meaning the device provides consistent results. |
| Intended Use Conditions: | The device was evaluated under intended use conditions (POL/physician's office settings). | The study confirms the device performs as expected in its target environment. |
| Targeted Population: | Patients except neonates and children under 6 months. | The study included samples from diabetic and non-diabetic subjects, aligning with the targeted population. |
Study Details
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Sample Size Used for the Test Set:
- 152 venous whole blood clinical samples
- 152 capillary finger stick blood samples
- 10 additional venous whole blood samples (spiked to 3 different glucose concentrations)
- Total: 314 samples
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Data Provenance: Retrospective and prospective. Clinical samples were obtained from 3 different physician's office sites (indicates prospective collection). The additional 10 spiked samples were generated "in house." Country of origin is not explicitly stated but implied to be the US, given the FDA submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not applicable. For glucose meters, the ground truth is established by a reference laboratory method (Hexokinase) or a highly accurate predicate device (YSI 2300 STAT PLUS Analyzer), not by human experts interpreting results.
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Adjudication Method for the Test Set: Not applicable. Glucose measurements are quantitative and are directly compared to the reference methods, not adjudicated by human consensus.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. This type of study is typically performed for imaging or interpretive diagnostic devices where human reader performance is a key factor. This is a standalone diagnostic device.
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Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Yes, this was a standalone study. The performance of the Stat-Site®/GlucoSite® Test System was directly compared to the reference methods. Human interpretation or assistance is not part of the device's function or the study design.
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Type of Ground Truth Used:
- Reference Method: Hexokinase plasma glucose method.
- Predicate Device: YSI 2300 STAT PLUS Analyzer (also a highly accurate glucose measurement device).
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Sample Size for the Training Set: Not explicitly stated as a separate "training set." For this type of device, calibration and internal algorithm development would occur during the device's R&D phase, likely using a different set of samples. The described study focuses on validation using clinical and spiked samples.
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How the Ground Truth for the Training Set Was Established: Not detailed in this summary. However, typically, the ground truth for calibrating such a device would also be established using highly accurate laboratory reference methods like Hexokinase on a large set of samples covering the intended measurement range.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.